Navigator HD M0062502230Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729837985), received between Oct 3, 2017 and Sep 22, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Nonstandard Device; Material Deformation

  It was reported that a Navigator was used during a procedure. Reportedly, it was found that the tip of the dilator was damaged. The procedure was completed with another of the same device with no patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852828 ↗
• MalfunctionSep 14, 2026Unsealed Device Packaging

  It was reported that a Navigator Access Sheath device was set to be used during a procedure. Reportedly, it was found that the sealing label was peeled off. Additionally, there was no damage to the outer box. There was no patient or procedure involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754795 ↗
• MalfunctionSep 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING PREPARATION, THEY NOTICED A SCRATCH AT THE END OF THE OUTER SHEATH'S DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069820 ↗
• MalfunctionApr 4, 2025Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USE DURING URETERAL LITHOTRIPSY PROCEDURE. DURING UNPACKING IT WAS FOUND THAT THE URETERAL SHEATH INNER CORE WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772956 ↗
• MalfunctionDec 9, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A LITHOTOMY UNDER FLEXIBLE ENDOSCOPE PROCEDURE. DURING THE PROCEDURE, THE URETERAL SHEATH WAS DAMAGED. ADDITIONALLY, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885507 ↗
• MalfunctionNov 20, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE INSIDE WAS STICKING OUT SHARPLY AND CAN BE SEEN THROUGH SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735741 ↗
• MalfunctionOct 18, 2024Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE, WHEN THE NAVIGATOR ACCESS SHEATH WAS ABOUT TO BE INSERTED, IT WAS OBSERVED FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487175 ↗
• MalfunctionJul 17, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE KIDNEY DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2023. AFTER ACTIVATING THE COATING, THE SHEATH WAS INSERTED INTO THE PATIENT; HOWEVER, A CRACKING SOUND WAS HEARD DURING INSERTION. WHEN INSPECTED OUTSIDE THE PATIENT, IT WAS FOUND THAT THE SHEATH WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER SHOW THE SHEATH WAS FRACTURED AND THE FRACTURED SITE WAS SLIGHTLY BENT. IT COULD ALSO BE OBSERVED THAT THERE WERE WHITENED AREAS ADJACENT TO THE FRACTURED SITE, INDICATING THAT THE MATERIAL WAS SUBMITTED TO TENSION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334030 ↗
• MalfunctionJul 14, 2023Difficult to Insert; Material Integrity Problem; Material Split, Cut or Torn; Difficult to Insert; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS PREPARED FOR USE IN THE KIDNEY TO TREAT A 3CM STONE DURING A SOFT URETEROSCOPIC PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PREPARATION, THE PHYSICIAN SOAKED THE OUTER SHEATH WITH NORMAL SALINE; HOWEVER, IT WAS FELT THAT THE COATING WAS NOT SUCCESSIVELY SMOOTH. THERE WAS RESISTANCE IN THE PROCESS OF ENTERING THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON ANALYSIS OF THE RETURNED DEVICE WHICH FOUND THAT THE SHEATH FRACTURED NEAR DISTAL END. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324149 ↗
• MalfunctionApr 4, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A URETERAL CALCULUS PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE URETERAL SHEATH WAS PLACED; HOWEVER, IT WAS NOTICED IN THE SCOPE VIEW THAT THE INNER WALL OF THE SHEATH WAS LIFTED UP. IT WAS REPORTED THAT THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. NOTE: A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING THE INNER LINING OF THE SHEATH WAS PEELED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676240 ↗
• MalfunctionJan 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED A RIGID URETEROSCOPE PROCEDURE PERFORMED ON (B)(6) 2022.. DURING THE PROCEDURE, THE DEVICE ENTERED THE PATIENT AND COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE SHEATH WAS FOUND TO BE FRACTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122501 ↗
• MalfunctionJun 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS TO BE USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6),2022. DURING PREPARATION, IT WAS NOTICED THAT THE SHEATH WAS BROKEN WHEN OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS THE SHEATH WAS BROKEN INSIDE THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14618768 ↗
• MalfunctionJun 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT NAVIGATOR HD DEVICE WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SHEATH APPEARED BRITTLE AND BROKE IN MULTIPLE PLACES. REPORTEDLY, THE WIRE INSIDE THE SHEATH MADE IT POSSIBLE TO EASILY RETRIEVE THE FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602000 ↗
• MalfunctionMar 17, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED IN THE URETER DURING A FLEXIBLE TRANSURETHRAL URETEROLITHOTRIPSY (F-TUL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT PART OF THE DILATOR HUB GOT CAUGHT AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHEATH TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792480 ↗
• MalfunctionFeb 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED IN THE URETER DURING A URETERAL CALCULUS PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS FOUND THAT THE SHEATH CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13513644 ↗
• MalfunctionDec 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE SHEATH WAS NOTED SPLIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087170 ↗
• MalfunctionOct 11, 2021Defective Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Defective Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS UNPACKED FOR A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2021. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS IN A POOR CONDITION. PHOTO SUBMITTED BY THE CUSTOMER CONFIRMED THAT THE SHEATH WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHERNAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **CORRECTION** DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS IN A POOR CONDITION. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHEATH TORN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605194 ↗
• MalfunctionSep 27, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE EXTRACTION OF A STONE FRAGMENT, IT WAS NOTICED THAT THE INTERNAL LINING OF THE SHEATH WAS PARTIALLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532051 ↗
• MalfunctionSep 22, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS UNPACKED TO BE USED IN THE PELVIS CALCULI FOR A TRANSURETEROSCOPIC HOLMIUM LASER LITHOTRIPSY WITH LUMINAL DILATION PROCEDURE PERFORMED ON (B)(6) 2021. WHILE UNPACKING, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS TILTED AND COULD NOT BE USED. THE PROCEDURE WS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511682 ↗
• MalfunctionJul 21, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE REMOVAL OF THE SHEATH AFTER THE PROCEDURE, IT WAS NOTICED THAT THE INNER LINING OF THE SHEATH WAS COMING OFF AND WAS COMING OF THE SHEATH. THE PROCEDURE WAS COMPLETED AT THIS TIME. REPORTEDLY, NO PIECE OF THE DEVICE DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206527 ↗
• MalfunctionJul 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS UNPACKED TO BE USED IN THE LEFT KIDNEY FOR A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE ON (B)(6) 2021. DURING PERPARATION, IT WAS NOTED THAT THE DISTAL TIP OF THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172316 ↗
• MalfunctionDec 15, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE UPPER URINARY TRACT DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE CAME RIGHT OFF AWAY WHEN IT WAS TOUCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11010990 ↗
• MalfunctionMar 20, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED IN THE URETER DURING A REMOVAL OF KIDNEY STONE PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE INNER DILATOR BROKE OFF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860713 ↗
• MalfunctionFeb 25, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED IN THE PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN WAS NOT ABLE TO SEE THROUGH THE PRODUCT AND COULD NOT ADVANCE THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. INVESTIGATION RESULTS REVEALED THAT THE SHEATH WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749582 ↗
• MalfunctionDec 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SHEATH WAS FOUND BROKEN IN HALF WHEN REMOVED FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418839 ↗